In this issue of THE JOURNAL, Lasser and colleagues1
examine the timing and nature of the black box warnings added to labeling,
as reflected in the Physicians' Desk Reference, and
of removal of drugs from the market to address the question of whether clinicians
should hesitate to prescribe new drugs that may have unrecognized adverse
drug reactions (ADRs). Premarketing trials in a few thousand (usually relatively
uncomplicated) patients do not detect all of a drug's adverse effects, especially
relatively rare ones. Frequent postmarketing labeling changes are therefore
inevitable and should be anticipated. Sometimes the new information is so
important it fundamentally changes the place of the drug in therapy (eg, leads
to second-line status) and sometimes the postmarketing discoveries cause the
drug to be withdrawn.
Some tools below are only available to our subscribers or users with an online account.
Download citation file:
Web of Science® Times Cited: 89
Customize your page view by dragging & repositioning the boxes below.
More Listings atJAMACareerCenter.com >
Users' Guides to the Medical Literature
Can I Apply the Results of the Study to My Patient?
All results at
Enter your username and email address. We'll send you a link to reset your password.
Enter your username and email address. We'll send instructions on how to reset your password to the email address we have on record.
Athens and Shibboleth are access management services that provide single sign-on to protected resources. They replace the multiple user names and passwords necessary to access subscription-based content with a single user name and password that can be entered once per session. It operates independently of a user's location or IP address. If your institution uses Athens or Shibboleth authentication, please contact your site administrator to receive your user name and password.